Catheter Related InfectionsNCT01772875
Bladder Lavage as Decontamination Method for Asymptomatic Bacteriuria With Uropathogens in Catheterized Patients
A study testing bladder lavage in people with Catheter Related Infections, run by National Multiple Sclerosis Center at 1 site in Belgium.
Trial summary
In patients with advanced multiple sclerosis, permanent urinary catheters are often used to manage the urinary incontinence and bladder emptying problems. These catheters will lead to urinary tract infection, blocking of the catheter etc.. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Catheter Related Infections
- What is being tested?
- bladder lavage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2013to 20 Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with an indwelling catheter
- catheter associated bacteriuria with proteus, enterobacteriaceae or pseudomonas
- willing and able to give informed consent to the study
Who cannot join
- patients with a clinically relevant UTI ( fever, pain or cloudy urine)
- cognitively impaired patients
- patients not able or willing to give informed consent
- patients with allergies for ISobetadine dermicum or other substances used in the protocol
- patients who only have a catheter for less than 1 month
- patients taking systemic antibiotics during the last 48h
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study to Evaluate the Efficacy of Antiseptic Bladder Lavage Versus Pulsatile Lavage With Physiologic Serum in Catheterized Patients With Asymptomatic Bacteriuria With Uropathogens.
In patients with advanced multiple sclerosis, permanent urinary catheters are often used to manage the urinary incontinence and bladder emptying problems. These catheters will lead to urinary tract infection, blocking of the catheter etc.. Especially infections with certain bacteria such as proteus, enterobacteriaceae and ESBL producing enterobacteriaceae and pseudomonas can pose a problem for the hospital infection control and for the patient.
This study wants to evaluate the potential role of regular bladder lavage with saline, a solution of betadine, an acid solution of acetic acid and of URotainer Twin Suby G ( Braun)in the decontamination of these bladders and the prevention of clinically relevant urinary tract infections.
Read the detailed description
PAtients will be selected from the catheterised patient population of the National MS Center in Belgium for this prospective randomised comparative pilot studyon bladder lavage.
The potential benefit for the patient is a reduction in number of clinical urinary tract infections and a reduction of antibiotic use.
According to the type of bacteria that is cultured from the urine, patients will be allocated to one of 4 subgroups:
- 30 patients will recieve bladder lavage with a Isobetadine Dermicum Solution
- 20 patients will revieve bladder lavage with acetic acid solutions
- 10 patients will recieve bladder lavage with saline
- 10 patients will receive bladder lavage with Urotainer Suby G
The effect will be measured by two repeat urine cultures after the bladder lavage( 2days and 5 days).
From a safety perspective and to assess the irritation caused by the lavage, white blood cell counts in the urine will be done.
Adverse events will be monitored according to GCP regulations.
- Conditions
- Catheter Related Infections
- Being tested
- bladder lavage
- Keywords
- urinary catheter, UTI, bladder lavage
- Medical subject headings
- Catheter-Related Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bladder lavageProcedure or surgery
Also called bladder rincing
the bladder is rinced through the urinary catheter with the lavage solution
| Study group | Role | What they receive |
|---|---|---|
| lavage Isobetadine Dermicum solution | Active comparator | Patient will receive 1 bladder lavage daily with a solution of 5ml Isobetadine Dermicum in 100cc saline Receives: Procedure: bladder lavage |
| lavage Acetic Acid solution | Active comparator | Patients will receive a daily bladder lavage during 5 consecutive days with a solution of 0.5% acetic acid in 100cc of saline Receives: Procedure: bladder lavage |
| lavage with saline | Sham comparator | patients will receive during 5 consecutive days a bladder lavage with 100cc saline Receives: Procedure: bladder lavage |
| lavage Urotainer Suby G | Active comparator | patients will receive during 5 consecutive days a bladder lavage with 100cc of Urotainer Suby G Receives: Procedure: bladder lavage |
What is being measured
The primary outcome is the main question the study is designed to answer.
urinary culture
After 5 consecutive days of bladder lavage, a urine culture will be taken at day 2 and 5. A count of <100.000 CFU/ml and is considered a positive result.
The outcome will be considered positive if this positive result is found in more than 30% of subjects.
Measured: day 2 and day 5 after last bladder lavage
Secondary outcomes (1)
pyuria
changes in white blood cell count are monitored at day 2 and 5 afte 5 consecutive days of bladder lavage. This is an assessment of bladder irritation.
Measured: day 2 and day 5 after the last bladder lavage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2013 (estimated)
- Study startJan 2013 (estimated)
- Primary completionDec 2013 (estimated)
- Study completion20 Jan 2014
Why it stopped: no clinical investigator present
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Catheter Related InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Multiple Sclerosis Center
- Sponsor type
- University, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven
- Responsible party
- Principal investigator, Daphne Kos, National Multiple Sclerosis Center
- Investigators
- Dirk De Ridder, Prof., Principal investigator, National MS Center Belgium & University Hospitals KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01772875
- Sponsor's protocol ID
- BLLAV-1
- Status last verified
- Aug 2020
- First submitted
- 17 Jan 2013
- Last updated
- 5 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jaggi N, Sissodia P. Multimodal supervision programme to reduce catheter associated urinary tract infections and its analysis to enable focus on labour and cost effective infection control measures in a tertiary care hospital in India. J Clin Diagn Res. 2012 Oct;6(8):1372-6. doi: 10.7860/JCDR/2012/4229.2362.
PubMed 23205350
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Evaluate the Efficacy of Antiseptic Bladder Lavage Versus Pulsatile Lavage With Physiologic Serum in Catheterized Patients With Asymptomatic Bacteriuria With Uropathogens.
- ClinicalTrials.gov ID
- NCT01772875
- Acronym / sponsor ID
- BLLAV-1
- Conditions
- Catheter Related Infections
- Keywords
- urinary catheter, UTI, bladder lavage
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no clinical investigator present
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Multiple Sclerosis CenterUniversity, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven
- Study start
- Jan 2013 (estimated)
- Primary completion
- Dec 2013 (estimated)
- Study completion
- 20 Jan 2014 (actual)
- First posted
- 21 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In patients with advanced multiple sclerosis, permanent urinary catheters are often used to manage the urinary incontinence and bladder emptying problems. These catheters will lead to urinary tract infection, blocking of the catheter etc.. Especially infections with certain bacteria such as proteus, enterobacteriaceae and ESBL producing enterobacteriaceae and pseudomonas can pose a problem for the hospital infection control and for the patient.
This study wants to evaluate the potential role of regular bladder lavage with saline, a solution of betadine, an acid solution of acetic acid and of URotainer Twin Suby G ( Braun)in the decontamination of these bladders and the prevention of clinically relevant urinary tract infections.
Detailed description
PAtients will be selected from the catheterised patient population of the National MS Center in Belgium for this prospective randomised comparative pilot studyon bladder lavage.
The potential benefit for the patient is a reduction in number of clinical urinary tract infections and a reduction of antibiotic use.
According to the type of bacteria that is cultured from the urine, patients will be allocated to one of 4 subgroups:
- 30 patients will recieve bladder lavage with a Isobetadine Dermicum Solution
- 20 patients will revieve bladder lavage with acetic acid solutions
- 10 patients will recieve bladder lavage with saline
- 10 patients will receive bladder lavage with Urotainer Suby G
The effect will be measured by two repeat urine cultures after the bladder lavage( 2days and 5 days).
From a safety perspective and to assess the irritation caused by the lavage, white blood cell counts in the urine will be done.
Adverse events will be monitored according to GCP regulations.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| lavage Isobetadine Dermicum solution | Active comparator | Procedure: bladder lavagePatient will receive 1 bladder lavage daily with a solution of 5ml Isobetadine Dermicum in 100cc saline |
| lavage Acetic Acid solution | Active comparator | Procedure: bladder lavagePatients will receive a daily bladder lavage during 5 consecutive days with a solution of 0.5% acetic acid in 100cc of saline |
| lavage with saline | Sham comparator | Procedure: bladder lavagepatients will receive during 5 consecutive days a bladder lavage with 100cc saline |
| lavage Urotainer Suby G | Active comparator | Procedure: bladder lavagepatients will receive during 5 consecutive days a bladder lavage with 100cc of Urotainer Suby G |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients with an indwelling catheter
- catheter associated bacteriuria with proteus, enterobacteriaceae or pseudomonas
- willing and able to give informed consent to the study
Key exclusion criteria (6 listed)
- patients with a clinically relevant UTI ( fever, pain or cloudy urine)
- cognitively impaired patients
- patients not able or willing to give informed consent
- patients with allergies for ISobetadine dermicum or other substances used in the protocol
- patients who only have a catheter for less than 1 month
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bladder lavageAlso: bladder rincingthe bladder is rinced through the urinary catheter with the lavage solution | Procedure or surgery | lavage Acetic Acid solution, lavage Isobetadine Dermicum solution, lavage Urotainer Suby G, lavage with saline |
Primary outcome
urinary culture
Time frame: day 2 and day 5 after last bladder lavage
After 5 consecutive days of bladder lavage, a urine culture will be taken at day 2 and 5. A count of <100.000 CFU/ml and is considered a positive result. The outcome will be considered positive if this positive result is found in more than 30% of subjects.
1 secondary outcome
pyuria
Time frame: day 2 and day 5 after the last bladder lavage
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2020.
- Background: PubMed 23205350Jaggi N, Sissodia P. Multimodal supervision programme to reduce catheter associated urinary tract infections and its analysis to enable focus on labour and cost effective infection control measures in a tertiary care hospital in India. J Clin Diagn Res. 2012 Oct;6(8):1372-6. doi: 10.7860/JCDR/2012/4229.2362.
- website of the National MS Center, BelgiumLink provided by the sponsor.
Related trials for Catheter Related Infections
Not yet recruitingObservational study
Novel Antimicrobial Solution to Prevent Infections
Kidney Stone, Infection
RecruitingPhase 4
Open-Label Study to Assess Safety and Time to Catheter-related Bloodstream Infections (CRBSI) in Subjects From Birth to < 18 Years of Age
Catheter-Related Infections
Recruiting
Effectiveness of the NowCath Foley in Reducing Catheter-Associated UTIs and Blockages in Long-Term Indwelling Catheter Users (REDUCE)
Urinary Catheters, Urinary Catheterization
Not yet recruitingObservational study
Efficacy and Safety of Peripherally Inserted Central Venous Catheters
Critical Illness, Catheter-Related Infections
RecruitingPhase 4
Secondary Prevention of VTE in Patients With Cancer and Catheter-Related Upper Extremity Deep Vein Thrombosis
Venous Thromboembolism, Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dirk De Ridder, Prof. principal investigator
National MS Center Belgium & University Hospitals KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bladder lavage in people with Catheter Related Infections, run by National Multiple Sclerosis Center at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
urinary culture (time frame: day 2 and day 5 after last bladder lavage). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01772875, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2020.